Quick Facts at a Glance
- Recall Date
- July 21, 2025
- Hazard Level
- HIGH
- Brands
- Finesse BTK Multicath, Summa Therapeutics
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Finesse BTK Multicath, Summa Therapeutics
- Product type
- Injectable Angioplasty Balloon Catheter
- Model numbers
- FS252251502, UDI-DI: 00810017490967
- Sizes
- 5 French sheath, 0.014" guidewire compatible, Balloon diameter 2.5mm, Balloon length 225mm, Catheter working length 150cm
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 21, 2025
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for the balloon in the device to not meet burst specifications.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SUMMA THERAPEUTICS, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
This is an over-the-wire injectable angioplasty balloon catheter used in cardiovascular interventions. It features a 2.5mm balloon diameter, 225mm balloon length, and a 150cm working length, with a 5 French sheath and 0.014" guidewire compatibility.
Why This Is Dangerous
A balloon not meeting burst specifications can fail during inflation, potentially causing vessel injury or other complications requiring further intervention.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians may need to pause procedures using this device pending replacement or refunds. The issue could cause procedure delays and additional costs for health facilities.
Practical Guidance
How to identify if yours is affected
- Verify device labeling for model FS252251502 and UDI-DI 00810017490967
- Check lot numbers 240502, 240095, 231296, 231296A, 240095A on packaging or device label
- Cross-check with recall notice to confirm if your units are affected
Where to find product info
Recall letter and FDA enforcement report provide identification details and remedy steps.
What timeline to expect
Remedies, including refunds or replacements, are expected to follow recall processing timelines typical for medical-device recalls (not specified in a
If the manufacturer is unresponsive
- Document all contact attempts with Summa Therapeutics
- If no response, escalate to hospital compliance and relevant regulatory bodies per local guidance
How to prevent similar issues
- Implement strict inventory screening for model FS252251502 and UDI-DI 00810017490967
- Verify device compatibility with 0.014" guidewires and 5 French sheath requirements before use
- Monitor for any recall notices from Summa Therapeutics or FDA
- Establish a recall response plan with clinical staff and supply chain
Documentation advice
Keep the recall letter, original packaging, labeling, and all correspondence with Summa Therapeutics; document lot numbers and device IDs for future audits.
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Product Details
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; Lots: 240502, 240095, 231296, 231296A, 240095A. Sold to facilities in New Jersey and Florida. Sold date: Unknown. Price: Unknown. Quantity: 22 units. Recall date: 2025-07-21. Status: ACTIVE. Distributor: Summa Therapeutics.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- NJ and FL facilities affected
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Safety Guide
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